Cel Sci Corporation (CVM)

[maverick1856]

here are some interesting excerpts from the Annual Report:

As of April 30, 2015, the last update given by CEL-SCI, the study had enrolled 437 patients. CEL- SCI expects to see a further increase in the number of patients enrolled in the study at an accelerating pace as (i) the current centers finalize all logistical issues and (ii) more clinical centers are added throughout the world. Although CEL-SCI is aiming to enroll 880 patients, the Phase 3 study requires a total of 784 evaluable patients. Ergomed’s goal is to reach full enrollment of the targeted number of 880 patients by the end of 2015; however, CEL-SCI is estimating that such enrollment will be completed in March 2016. In order to complete the targeted enrollment of 880 patients by March 2016, CEL-SCI is assuming a 4.3% increase in patients enrolled per month based on enrolling 31 patients during April 2015, up from 29 patients in March 2015, and based on a total enrollment of 437 patients as of April 30, 2015. Following full
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enrollment of the study, CEL-SCI has to wait for 298 events (deaths) in the two comparator arms combined to determine if CEL-SCI has met its primary endpoint, which is a 10% increase in overall survival in the Multikine arm over the comparator arm. CEL-SCI estimates that the final data read-out of this Phase 3 clinical trial could occur by the second half of 2017, based on the enrollment projections and estimated survival curves provided in scientific literature.

Of the 437 patients that have been enrolled in the study, uncertainty remains as to whether up to 117 patients enrolled during inVentiv’s tenure (the CRO who we dismissed in April 2013) as the global manager of the Phase 3 clinical trial will be considered to be evaluable subjects at the close of the study. CEL-SCI is currently engaged in a contract dispute (arbitration) alleging that inVentiv failed to comply with the protocol for the Phase 3 clinical trial and applicable regulatory requirements. CEL-SCI does not believe that it will need to replace all 117 of these patients, but assuming that all of these patients must be replaced, CEL-SCI estimates that it could take an additional two to three months to do so based on the current expectations of enrolling approximately 50 patients per month at the end of the scheduled enrollment period. However, the Phase 3 study design anticipates enrollment of a total of 880 patients, while the statistical analysis requires a total of 784 evaluable patients. Therefore, the actual number of patients enrolled by the former CRO that will need to be replaced and the time needed to do so cannot be determined at this time. The arbitration is tentatively scheduled for a hearing, the arbitration equivalent of a trial, on October 27, 2015.

LEAPS is protected by patents in the United States issued in February 2006, April 2007 and August 2007. TheLEAPSpatents,whichexpirein2021,2022and2022,respectively,includeoverlappingclaims, with composition of matter (new chemical entity), process and methods-of-use, to maximize and extend the coverage in their current format. Additional patent applications are pending in the United States and Europe that could offer protection through 2034.
CEL-SCI has six patent applications pending in the United States and one in Europe for LEAPS, which, if issued, would extend protection through 2034, subject to any potential patent term extensions. Two pending U.S. applications are joint applications with Northeast Ohio Medical University (“Neoucom”), and one is a joint application with the National Institutes of Health (“NIH”). If granted, CEL-SCI will share the ability to use the patents, unless CEL-SCI licenses the rights to the patent application and any ensuing patent from Neoucom or NIH.